OsteoporosisNCT03359317
Jogging in the Change of Osteoporosis
A study testing jogging in people with Osteoporosis, run by Peking University People's Hospital.
Trial summary
To test the changes in osteoarthritis according to the X-rays, and changes in bone quality before and 1 or more years after beginning the jogging Read more about this study
- Who is it for?
- Ages 50 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- jogging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2018to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Past DEXA scan and, all within 6 months of study entry, DEXA scan and normal values for: Metabolic panel, TSH, PTH, ESR (or CRP), Vitamin D 25 hydroxy, Vitamin D 1,25 dihydroxy, Urine NTX
Who cannot join
- Known metabolic bone disease such as osteogenesis imperfecta, current treatment with steroids, chemotherapy, or currently healing fractures of lumbar spine, hips or femurs, severe heart disease
Trial locations and contacts
No sites are listed yet.
About this study
To test the changes in osteoarthritis according to the X-rays, and changes in bone quality before and 1 or more years after beginning the jogging
Read the detailed description
Patients in this research are given an entry Bone Densitometry（DEXA）scan and are required to advance from 3-minute jogging a day to 10-minute level in daily practice for 1 year as instructed. After 1 year, subsequent DEXA scans are recorded. Interested participants are also encouraged to have hip and spine X-rays, and bone quality studies on study entry and two years later. Actual subject participation, intercurrent illnesses, fractures and changes in medication are self-monitored. Results are calculated by change in bone mineral density in the lumbar spine, hips and femurs by the DEXA scan in the study. Dose-response relationships between the amount of jogging and bone mineral density are sought. Jogging-related fractures and other adverse effects are also noted.
- Conditions
- Osteoporosis
- Being tested
- jogging
- Keywords
- Osteoporosis, Bone Diseases
- Medical subject headings
- Osteoporosis, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
joggingBehavioural
Jogging as instructed for 1 year
| Study group | Role | What they receive |
|---|---|---|
| jogging | Experimental | At least 5 times/week Receives: Behavioral: jogging |
What is being measured
The primary outcome is the main question the study is designed to answer.
DEXA T-score
Bone mineral density change in spine, hip and femur after 1 year of jogging
Measured: 1 year
Secondary outcomes (1)
Number of fractures
Number of fractures occurring while in study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start20 Feb 2018 (estimated)
- Primary completion30 Jan 2019 (estimated)
- Study completion30 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Sun Yat-sen Cardiovascular Hospital, Wujin People's Hospital, Chongqing Zhongshan Hospital
- Responsible party
- Principal investigator, Zhang Yichong, Peking University People's Hospital
- Investigators
- Peixun Zhang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359317
- Sponsor's protocol ID
- PKUPH-JGO
- Status last verified
- Nov 2017
- First submitted
- 26 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jogging in the Change of Osteoporosis
- ClinicalTrials.gov ID
- NCT03359317
- Acronym / sponsor ID
- PKUPH-JGO
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Bone Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Sun Yat-sen Cardiovascular Hospital, Wujin People's Hospital, Chongqing Zhongshan Hospital
- Study start
- 20 Feb 2018 (estimated)
- Primary completion
- 30 Jan 2019 (estimated)
- Study completion
- 30 Jan 2019 (estimated)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the changes in osteoarthritis according to the X-rays, and changes in bone quality before and 1 or more years after beginning the jogging
Detailed description
Patients in this research are given an entry Bone Densitometry（DEXA）scan and are required to advance from 3-minute jogging a day to 10-minute level in daily practice for 1 year as instructed. After 1 year, subsequent DEXA scans are recorded. Interested participants are also encouraged to have hip and spine X-rays, and bone quality studies on study entry and two years later. Actual subject participation, intercurrent illnesses, fractures and changes in medication are self-monitored. Results are calculated by change in bone mineral density in the lumbar spine, hips and femurs by the DEXA scan in the study. Dose-response relationships between the amount of jogging and bone mineral density are sought. Jogging-related fractures and other adverse effects are also noted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| jogging | Experimental | Behavioral: joggingAt least 5 times/week |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Past DEXA scan and, all within 6 months of study entry, DEXA scan and normal values for: Metabolic panel, TSH, PTH, ESR (or CRP), Vitamin D 25 hydroxy, Vitamin D 1,25 dihydroxy, Urine NTX
Key exclusion criteria (1 listed)
- Known metabolic bone disease such as osteogenesis imperfecta, current treatment with steroids, chemotherapy, or currently healing fractures of lumbar spine, hips or femurs, severe heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| joggingJogging as instructed for 1 year | Behavioural | jogging |
Primary outcome
DEXA T-score
Time frame: 1 year
Bone mineral density change in spine, hip and femur after 1 year of jogging
1 secondary outcome
Number of fractures
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peixun Zhang, MD principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing jogging in people with Osteoporosis, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peixun Zhang, MD (15210802766, 875274428@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DEXA T-score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.